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Skullcandy, Inc. Message Board

meifud 88 posts  |  Last Activity: Oct 3, 2015 6:50 PM Member since: Jun 3, 2009
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  • meifud meifud Oct 3, 2015 6:50 PM Flag

    well, i was just speculating based on screening resuming because that is what started the tumble but if you want to throw in news on reimbursement and/or patients being treated then that would just add to the rebound -- but just think what a stop for efficacy would do!

  • meifud meifud Oct 3, 2015 2:20 PM Flag

    "Even fact nothing happen material in own right.
    Common sense interpretation of material and not own."

    well, if you want to call nothing happening a 'material event' more power to you but unless you can find a bunch of folks to agree with that interpretation it doesn't sound like very 'common' sense

    and there is absolutely no requirement for Northwest or any company to report to shareholders on a month to month basis

    why can't you just accept that Northwest is doing what they said -- namely, conducting trials, negotiating rates with Germany, and expanding facilities? especially since it caused so much grief last year when Linda tried to keep shareholders apprised of interim progress that did not at all have to be revealed. i mean, fool me once and i'm the fool but try to fool me twice and...

  • meifud meifud Oct 3, 2015 1:12 PM Flag

    that's just your interpretation of a "material event" requiring filing

    there is no requirement for Northwest to tell shareholders day by day how many patients are being treated under the Hospital Exemption and, depending on how such unnecessary communication would be worded, it absolutely could be considered an attempt at marketing

  • yes, it was just 800 shares, but what a nice addition to a nice close for the day

  • meifud meifud Oct 2, 2015 10:59 AM Flag

    well, it's one or the other and you should certainly know the answer
    do i need to rephrase the question?

  • meifud meifud Oct 2, 2015 9:02 AM Flag

    i feel your pain BUT anything that could be construed as "marketing" ist forboten under the terms of the Hospital Exemption. so Northwest is likely not even engaged in word of mouth with doctors, and the best course of action for patients and the company may just be to keep shareholders in the dark for now

  • what bmapes was responding to was a suggestion that Northwest has been treating patients with the understanding that when the reimbursement rate negotiations are finished, they will apply retroactively. what bmapes posted...

    "Well, based on the following quotes from last year's press release announcing the start of treatments, it sure sounds like they had more than one patient in the process. So, the recent information from Fraunhofer's annual report confirms they have been treating patients since that time and it appears they not waiting for resolution on pricing and reimbursement:, but rather submitting applications for approval or reimbursement. I am assuming that once approved, the only question remaining is what they will be reimbursed.

    "The first patient with Glioblastoma multiforme (GBM) brain cancer has begun the treatment process, additional patients are being assessed and a waiting list has been established"
    "This first patient is a German citizen and has already submitted his application for approval of reimbursement. Discussions with the Sickness Funds (insurers) about pricing and reimbursement are ongoing."

    Maybe they agreed to treat patients and gather data around efficacy and cost to manufacture, as part of establishing the reimbursement amount. Sure sounds like they could have a healthy backlog of reimbursements coming, which could be the reason for not announcing new financing. Perhaps they are close to getting reimbursement."

  • did you increase your short position 25%, meaning you shorted more, or did the value of your short position simply increase 25%

  • meifud meifud Sep 30, 2015 7:33 PM Flag

    it's very possible that Northwest has been providing these treatments w/o compensation but with the understanding that they will eventually be reimbursed once the rates are negotiated

    reminder for those who think these patients being treated is worthy of a press release -- Northwest is prohibited from "marketing" under the terms of the Hospital Exemption

    nevertheless, it seems some revenues should be showing up for non-German citizens are are going to Germany and are required to pay for their treatment

  • meifud meifud Sep 30, 2015 8:40 AM Flag

    seems some on this board are not aware this is an Elite/Epic drug that was just approved

  • meifud meifud Sep 29, 2015 10:32 PM Flag

    the approval letter gives Epic 14 days from the date of approval, September 22nd, to submit labeling, and this is an approval not a tentative approval...

    "As soon as possible, but no later than 14 days from the date of this letter, submit, using the FDA
    automated drug registration and listing system
    (eLIST), the content of labeling [21 CFR
    314.50(l)] in structured pr
    oduct labeling (SPL) format, as described at
    , that is
    identical in content to the approved labeling (including the package insert, and any patient
    package insert and/or Medication Guide that may be required). Information on submitting SPL
    files using eLIST may be found in the guidance fo
    r industry titled “SPL Standard for Content of
    Labeling Technical Qs and As” at
    . The SPL will be accessible via publicly available labeling repositories."

  • meifud meifud Sep 29, 2015 10:25 PM Flag

    don't know
    the report shows the date of approval (yes, the letter says approved!) as last Tuesday
    here are the opening paragraphs of the letter
    Food and Drug Administration
    Silver Spring, MD 20993
    ANDA 202662
    Epic Pharma, LLC
    227-15 North Conduit Avenue
    Laurelton, NY 11413
    Attention: Enna Krivitsky
    Director Regulatory Affairs
    Dear Madam:
    This is in reference to your abbreviated ne
    w drug application (ANDA) dated January 21, 2011,
    submitted pursuant to section 505(j) of the Fede
    ral Food, Drug, and Cosm
    etic Act (the FD&C
    Act), for Oxycodone Tablets USP, 5 mg, 10 mg, 15 mg, and 30 mg.
    Reference is also made to the
    Complete Response Letter issued by this office on February 4,
    2014 and to your amendments dated July 2, 2014; June 10, August 11, and September 11, 2015.
    We have completed the review of this ANDA and
    have concluded that ade
    quate information has
    been presented to demonstrate that the drug is safe and effective for use as recommended in the
    submitted labeling.
    Accordingly the ANDA is approved
    , effective on the date of this letter. The
    Division of Bioequivalence has
    determined your Oxycodone Tablets USP, 5 mg, 15 mg, and
    30 mg to be bioequivalent, and therefore ther
    apeutically equivalent, to the listed drug
    Roxicodone Tablets, 5 mg, 15 mg and 30 mg, of
    Mallinckrodt Inc., respectively. The drug
    product, Oxycodone Tablets USP, 10 mg, can be expect
    ed to have the same therapeutic effect as
    that of the listed drug product upon which the
    Agency relied as the basis of safety and
    effectiveness. Your dissolution testing should
    be incorporated into the stability and quality
    control program using the same me
    thod proposed in your application"

  • meifud meifud Sep 29, 2015 6:13 PM Flag

    would be surprised if this link is allowed, but will try posting anyhow...

    and if that doesn't work, you can get to it as i did doing a search for oxycodone hydrocloride epic pharma approved

  • however, the category is "approved or tentatively approved"
    also, no label yet available

  • nobody wants biotech showing up on their quarterly statements, so they are dumping

    if that has been a big factor in the across the board crushing of biotech the past couple of trading days then the sector should stabilize today and tomorrow because funds don't wait until the last minute, and some recovery should get underway later this week

    what precipitated all this was a confluence of hillary's posturing over prescription drug costs coupled with very large short positions in many, many issues which was the consequence of biotech being so strong for so long

    now is the time to keep in mind that you likely bought NWBO because Northwest has a story unlike any stock in any sector -- a story that is now taking hold with Woodford, Goldman, Blackrock, Credit Suisse and other institutions as evidenced by their aggressive buying this year

    bottom line is buy more whenever you have the money to do so because everything in this price range is going to look very small in the rear view mirror one day soon

  • meifud meifud Sep 25, 2015 7:39 AM Flag

    we don't know who the bondholders were, so who's to say it wasn't Toucan which would make it a questionable circular backdoor financing arrangement

    but the strong argument against Toucan or any friendly being the bondholder is the fact that Cognate had to pay a $900k penalty to Northwest for early redemption of the warrants -- which, unfortunately, raises the question of how that could have happened with Linda being on the board of Cognate

    wish Linda would have just sold a convertible bond to the public (giving shareholders a chance to help fund Northwest) and used the proceeds to pay Cognate in cash instead of warrants

  • meifud meifud Sep 24, 2015 11:59 PM Flag

    "Okay, just so I understand. Cognate sold $17 Million of warrants to pay for 5% convertible bonds?"
    Cognate raised some amount(?) of money for itself by selling bonds paying 5% that were convertible into NWBO shares which Cognate had rights to via warrants it had received as payment for services rendered to Northwest some time ago (which is why the conversion price was so low)
    the bondholders opted to exercise their conversion rights, so Cognate exercised its warrants and delivered the shares to the bondholders

  • meifud meifud Sep 24, 2015 11:04 AM Flag

    dantrolene should be getting approved fairly soon and may be a lot bigger than the current generics

    regardless, quarterly revenue increases of at least 50% year over year should be common place for a long time to come what with the generics that are just waiting for change of location approval

    and then we have the abuse resistant line which promises to not only dominate the pain market but also expand the oxy market as doctors become more comfortable prescribing what has been the most abused prescription drug on the market but remains the go to drug for patients experiencing break through pain

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